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Cardio Flow Peripheral Guide Wire

FDA UDI

Class II (US FDA UDI)

by Cardio Flow Inc.,

Identity

Trade Name
Cardio Flow Peripheral Guide Wire FDA UDI
Generic Name
Peripheral vascular guidewire, manual FDA UDI
Device Name
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM FDA UDI
Model / Reference
GW1001 FDA UDI
Description
Cardio Flow Peripheral Guide Wire Guidewire, 325 CM FDA UDI

Identifiers

Primary DI / UDI-DI
00850040691009 FDA UDI
510(k) Number
K213834 FDA UDI
FDA Product Code
DQX FDA UDI
GMDN Term
Peripheral vascular guidewire, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Dimensions & Sizes

Size
Guidewire Length — 325 Centimeter FDA UDI

Category: Peripheral vascular guidewire, manual

Cardio Flow Peripheral Guide Wire by Cardio Flow Inc., — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral vascular guidewire, manual.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardio Flow Inc.,

Sources (1)

  • FDA UDI d7ade07e-ceaa-47e3-94fd-5a4465823367 37 fields · synced Jun 8, 2026